ENIMERA REGS+ HAS EXTENSIVE REGULATORY EXPERIENCE, SUPPORTING SERVICES ACROSS A RANGE OF PRODUCT TYPES.
Generic Medicines
Medical Technologies
Vitamins, Herbal and Mineral Supplements
Commercialisation
- Stakeholder Engagement and Policy
- Development of strategic advocacy plans
- Facilitating input to consultation documents
- Regulatory Strategy
- Development of Regulatory Strategies
- Leading TGA and Medsafe meeting efforts
- TGA Appeals an FOI requests
- Regulatory Applications
- Preparation of and/or review of
- Project Management
- Other projects as defined
- Pharmacovigilance
- QPPVA role
- Local literature searches
Effectiveness and Productivity
- Education and Mentoring
- Education across the Scientific Affairs Disciplines, including leader development
- On-site and remote (on-line tutorials)
- Mentoring programs
- Productivity and Effectiveness
- Individual mentoring
- Team education and mentoring
- Team effectiveness checks
Translational Research
- Bridging research and drug development
